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A Pychoeducational Intervention for Women With Diabetes (SWEEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sue Penckofer, Loyola University
ClinicalTrials.gov Identifier:
NCT01185561
First received: August 18, 2010
Last updated: October 19, 2016
Last verified: October 2016
  Purpose
This proposal describes a small randomized study to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. This program differs from other diabetes programs by focusing on the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes self-care behaviors will be discussed and measured, but they are not the primary focus of the intervention. The psychoeducational program will address: 1) education about how dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using Cognitive Behavioral Therapy (CBT). Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes.

Condition Intervention
Depression Anxiety Anger Behavioral: Psychoeducational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pychoeducational Intervention for Women With Diabetes

Resource links provided by NLM:


Further study details as provided by Sue Penckofer, Loyola University:

Primary Outcome Measures:
  • Center for Epidemiologic Studies Depression (CES-D) Score [ Time Frame: 6 Months ]
    The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.


Secondary Outcome Measures:
  • State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score [ Time Frame: 6 Months ]
    Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.

  • State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score [ Time Frame: 6 Months ]
    Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.

  • State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score [ Time Frame: 6 Months ]
    Scores on the The State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.


Enrollment: 74
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual medical care
Participants assigned to this arm represent the control group and will receive usual medical care only.
Experimental: Psychoeducational intervention
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Behavioral: Psychoeducational intervention
The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.

Detailed Description:

Diabetes is the fifth deadliest disease in the United States with no known cure, and cardiovascular disease (CVD) is the leading cause of death in persons with diabetes. Diabetes is the only disease that causes women to have as much heart disease as men. The relative risk of cardiac mortality has been reported to be 2.6 for women with diabetes as compared to 1.9 for men with diabetes after controlling for other cardiac risk factors. While cardiac mortality for men with diabetes has declined (13.1%), there has been a 23% increase in age-adjusted cardiac mortality for women with diabetes. This poor outcome, occurring in a time of significant advances in the management of heart disease, suggests the need to consider directing treatment at other risk factors. Depression may be one such risk factor.

Depression is an independent risk factor for CVD, and is associated with poorer self-management and decreased health-related quality of life. Approximately 25% of persons with diabetes have depression, and the rate of depression in women with diabetes is double that of men with diabetes. Women with diabetes exhibit worse diabetes self-care, glycemic control, and poorer quality of life than men with diabetes, which are exacerbated by depression. Other affective symptoms including anxiety and anger commonly accompany depressive symptoms appear to impose similar risks for poor medical outcomes, and occur more often in women with diabetes than men with diabetes.

Research has shown that treatment of depression with medication and/or cognitive behavioral therapy (CBT) effectively relieves depression and improves glycemic control in persons with diabetes. More recent evidence suggests that these benefits are more durable in patients treated with CBT vs. antidepressants alone. There has been no research on "symptom clusters" (i.e., depression, anxiety, and anger) in persons with diabetes, and their effect on glycemic control and self-management. In addition, a CBT program to treat a cluster of dysphoric symptoms has not been tested in persons with diabetes. Since women with diabetes have greater depression and anxiety, worse glycemic control, and increased cardiac mortality than men with diabetes, we are proposing to test the feasibility and effectiveness of a psychoeducational intervention to promote emotional health in women with type 2 diabetes.

This proposal describes a small randomized controlled trial to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. This program differs from other diabetes programs by focusing on the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes self-care behaviors will be discussed and measured, but they are not the primary focus of the intervention. The psychoeducational program will address: 1) education about how dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using CBT. A repeated measures, experimental design will be used. Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes. The aims and hypotheses for the study are:

Primary Aim: To determine the effect of a psychoeducational intervention on dysphoric symptoms. The primary hypothesis is that women receiving a psychoeducational intervention plus UMC will report fewer dysphoric symptoms (depression, anxiety, and anger) at three and six months follow-up.

Secondary Aim: To determine the effect of a psychoeducational intervention on glycemic control, diabetes self-management, and health-related quality of life. The secondary hypothesis is that women receiving a psychoeducational intervention plus UMC will have decreased hemoglobin A1c, report better diabetes self-management (increased self-care behaviors and self-efficacy), and report increased health-related quality of life (increased functional status, life satisfaction, and decreased diabetes-related distress) at three and six months follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged 18 to 75 years;
  2. have type 2 diabetes greater than six months and being medically managed
  3. score greater than or equal to 16 on the Center for Epidemiological Studies Depression (CES-D) scale which is indicative of depressive symptoms.
  4. score greater than or equal to 12 on the CES-D plus a history of depression or currently being treated for depression.

Exclusion Criteria:

Women with current alcohol or substance abuse disorders, or a history of bipolar depression or any other psychotic disorder will be excluded.

Women will also be excluded if they have a diabetes knowledge test score of less than 70% and severe complications of diabetes (blindness, renal failure, or major amputation which includes most toes, foot, knee, or leg)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185561

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Sue Penckofer, PhD Loyola University
  More Information

Responsible Party: Sue Penckofer, Professor, Loyola University
ClinicalTrials.gov Identifier: NCT01185561     History of Changes
Other Study ID Numbers: 108324
Study First Received: August 18, 2010
Results First Received: October 19, 2016
Last Updated: October 19, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Sue Penckofer, Loyola University:
Diabetes
SWEEP
Dysphoria

ClinicalTrials.gov processed this record on June 22, 2017